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Medical Device Quality Articles & Analysis
27 news found
Many medical devices are manufactured through plastic injection moulding, which allows for precise and top-quality components in large-scale production and better aligns with ISO standards. ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. ...
BySTEMart
In recent years, with the improvement of people's living standards and the pursuit of a healthy life, the medical device industry has developed rapidly. The demand for high-precision metal parts for medical devices has also increased. In terms of market size, the size of China's medical device ...
Recently, the Ministry of Industry and Information Technology, the National Health Commission and other 17 departments jointly issued the "robot" application action implementation plan to encourage the development of surgery, auxiliary examination, auxiliary rounds, intensive care, rehabilitation and other medical robot products, "robot The "robot" has ushered in a new round of ...
Once osteoporosis is diagnosed, there is no way for it to be reversed, so making bone density testing a regular part of your medical routine can at least help manage its effects on the body. Our medical devices use the highest level of technology to successfully test bone density and test the body with quality ultrasound and ...
” About Acumed, LLC Acumed serves highly skilled, specialized surgeons who demand comprehensive, high-quality medical devices for patients with simple to complex injuries for optimal restoration of function. ...
Sam will show us how to make quality a lifestyle at NuShores. And he will work with our experts to finalize and submit our first medical device for consideration by the FDA for use in humans. ...
In addition, he brings vast experience in FDA medical device submissions, Quality/Regulatory requirements for documentation, records and process qualification and Quality System Auditing. ...
Verification is critical for medical device testing, which is why we recommend reading part one if you haven’t already. In part one of this series, we examined the need for medical testing and briefly covered the first few aspects of device verification. ...
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. ...
Imbed Biosciences, Inc. announced today that it has been awarded a contract for $1,999,481 by the U.S. Army Medical Research and Development Command’s (USAMRDC) Military Infectious Diseases Research Program (MIDRP) to accelerate clinical development of an antibiofilm version of its next-generation Microlyte® Matrix wound dressing that can kill bacteria hidden in ...
Zenflow, Inc., a medical device company developing a minimally invasive treatment for enlarged prostate, or benign prostatic hyperplasia (BPH), has initiated the BREEZE™ pivotal clinical trial to evaluate its Spring System. ...
Imbed Biosciences Inc. is a privately held biotech company registered with the FDA as a medical device manufacturer with an ISO 13485 certified quality management system. ...
(OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing ...
Imbed Biosciences Inc. is a privately held biotech company registered with the FDA as a medical device manufacturer with an ISO 13485 certified quality management system. ...
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows ...
Mark is a manufacturing leader with a reputation as inventive and accomplished in medical device and biologic device manufacturing process development engineering and operations. ...
Computrol maintains its ISO 9001-2008 certification, ISO 13485 specific to medical device quality systems, AS9100 specific to military and aerospace quality systems, IPC class II and III and J-Std certified as well as being ITAR registered and lead-free RoHS ...
“The ECAT contract award allows for us to provide the Department of Defense with our most advanced medical products”, stated Doug Hughes, President and CEO of Optim. ...
The global healthcare sector is undergoing significant changes, requiring medical device manufacturing companies to keep up with the fast rate of development. As a pioneering company, B Medical Systems stimulates innovation in the medical device industry with patented solutions. ...